Identity
- Trade Name
- Weight Bear FDA UDI
- Generic Name
- Radiological arm/leg positioner FDA UDI
- Device Name
- A device for simulating a weightbearing position on a patient's foot during surgery or in a clinical setting. FDA UDI
- Model / Reference
- OI-100 FDA UDI
- Description
- A device for simulating a weightbearing position on a patient's foot during surgery or in a clinical setting. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00198168799079 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Radiological arm/leg positioner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6820 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Weight Bear by Orthios Innovations Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Orthios Innovations Llc
Sources (1)
- FDA UDI 4dfb31f9-7385-4738-b9ff-3e1f8b0617dc 35 fields · synced May 30, 2026